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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LONG TIBIAL CONNECTING BOLT ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE

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ZIMMER BIOMET, INC. LONG TIBIAL CONNECTING BOLT ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE Back to Search Results
Catalog Number 00249000521
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the threads were damaged. Attempts were made and no additional information is available at this time.
 
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Brand NameLONG TIBIAL CONNECTING BOLT
Type of DeviceORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13177554
MDR Text Key284721226
Report Number0001822565-2022-00027
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130595
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249000521
Device Lot Number62798341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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